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ZOLL Circulation, Inc. recalls 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the dis
Recalled December 3, 2014 · FDA recall Z-0477-2015 · ZOLL Circulation
Hazard
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed. · FDA Class II
Units
1 device
Sold at
One location in NC
Description
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
Manufacturer(s)
ZOLL Circulation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →